N/A
Completed N=5
Cryovagotomy Diabetes Trial
Source: ClinicalTrials.gov NCT04276051 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Hemoglobin A1c — 8.35; 8.86; 8.75; 8.40 percent of glycated hemoglobin
Summary
The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Aim 2 will evaluate differences in body weight and anthropometric measurements. This study will provide much needed data for a novel therapeutic intervention to manage obese patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c |
8.35; 8.86; 8.75; 8.40; 9.30 | — |
| PRIMARY Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
7.85; 4.70; 7.00; 10.70; 7.00 | — |
| PRIMARY Number of Deaths Among Recipients of the Cryoablation |
— | — |
| PRIMARY Number of Adverse Events Related to the Cryoablation |
— | — |
| SECONDARY Body Mass Index (BMI) |
37.25; 33.26; 37.25; 39.5 | — |
| SECONDARY Waist Circumference |
121.3; 147.66; 117.5; 127 | — |
| SECONDARY Waist-to-hip Ratio |
0.97; 1.06; 0.95; 1.0 | — |
| SECONDARY Total Cholesterol |
198.00; 194.33; 179.00 | — |
| SECONDARY Low-Density Lipoprotein (LDL) |
120.5; 121.33; 102.0 | — |
| SECONDARY Triglycerides |
110; 151; 85 | — |
| SECONDARY Systolic Blood Pressure |
127.00; 139.66; 112.50; 113.0 | — |
| SECONDARY Diastolic Blood Pressure |
80.00; 80.66; 74.00; 80.00 | — |
| SECONDARY Daily Caloric Intake |
— | — |
| SECONDARY Change in Anti-hyperglycemic Medication Regimen |
1; 1; 2 | — |
| SECONDARY Appetite Visual Analog Scale Score for Hunger |
98; 50; 60.5; 60.5; 26.5; 46 | — |
| SECONDARY Appetite Visual Analog Scale Score for Satisfaction |
2.5; 19; 37; 41.5; 72; 41.5 | — |
| SECONDARY Appetite Visual Analog Scale Score for Fullness |
2; 19.66; 37.5; 28.5; 77.5; 36 | — |
| SECONDARY Appetite Visual Analog Scale Score for Eating Quantity |
74.5; 42.33; 38; 52.5; 35; 45 | — |
| SECONDARY Appetite Visual Analog Scale Score for Desire for Certain Foods |
23.5; 49.33; 37; 41.5; 75; 71 | — |
| SECONDARY International Physical Activity Questionnaire (IPAQ) Score |
0; 1; 0; 2; 2; 0 | — |
| SECONDARY Fasting Glucose Level |
197; 166.33; 186.5; 151.5 | — |
| SECONDARY Fasting Insulin Level |
15.9; 11.6; 16.5; 18.65 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females between the ages of 22-65
- Diagnosis of type 2 diabetes mellitus (T2DM) for 3 months with thyroid stimulating hormone (TSH) in reference range at time of screening visit
- Systemic steroid use within 30 days prior to randomization
- Use of prescription or over the counter weight loss medications within 6 months prior to randomization
- Weight gain/loss >5% over the past 6 months
- Previous GI surgery or abnormal GI anatomy which may limit technical feasibility of the procedure
- Recent diagnosis of cardiovascular disease requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the past 6 months
- Abnormal pathologies or conditions of the GI tract, including peptic ulcers, hiatal hernia, active gallbladder disease, pancreatitis, cirrhosis, inflammatory bowel disease, upper GI bleed within 6 months of randomization
- Any condition or major illness that places the subject at undue risk by participating in the study
- Psychiatric condition rendering the subject unable to understand the possible consequences of the study
- Inability to provide informed consent
- Female subjects who have been pregnant within 6 months or breast-feeding at time of enrollment into the study, or women who plan to become pregnant within the next 12 months
- Diagnosis of anemia, red blood cell (RBC) transfusion in the preceding 3 months or expectation to receive transfusion within the next 12 months, or hemoglobinopathies that would affect HbA1c reliability
- Active or recent infection
- Immunosuppression
- History of coagulopathy or high risk for development of deep vein thrombosis (including congestive heart failure, those who are non-ambulatory, active leukemia/lymphoma, prior thrombotic events, family history of thrombosis)
- History of blood pressure instability (systolic BP ≤100 or ≥160 mmHg)
- History of autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
Data sourced from ClinicalTrials.gov (NCT04276051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.